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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000875-40 |
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Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trivalent influenza subunit vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2007/2008 |
| Measure | Description | Time Frame |
|---|---|---|
| HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1 | Tessenderlo | Belgium | ||||
| Site 2 |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Hamburg |
| Germany |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |